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This study is a single-center, parallel-group, randomized controlled trial with the following objectives: to compare the incidence of post-operative descemet membrane detachment (DMD) in phacoemulsification surgery between modified and conventional 2.2mm microincision.
2.2mm incision is considered an ideal incision size in phacoemulsification. However, DMD is a common and serious complication in 2.2mm microincision phacoemulsification for hard nucleus age-related cataract. DMD is originated from the incision in the operation. How to construct the appropriate incision shape and size for reducing the occurrence of DMD is an important problem to be solved urgently in phacoemulsification surgery.
The investigators found that enlarging the internal incision could increase the range of motion of surgical instruments and reduce the friction of instruments to incision. Therefore,the incidence of DMD would be reduced. The investigators developed this technique, modified 2.2mm incision, to reduce the incidence of incision-site DMD and not to increase other incision related complications.
In this trial, the investigators aim to compare modified and conventional 2.2mm incision with regard to safety and efficacy in reducing the incidence of DMD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| modified 2.2mm micoincision | Experimental |
| |
| conventional 2.2mm microincision | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| modified 2.2mm microincision | Procedure | enlarging the internal incision about 0.4mm for conventional 2.2mm coaxial microincision phacoemulsification |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of DMD at postoperative day 1 | Incidence of incision-site descemet membrane detachment observed by anterior segment OCT at postoperative day 1 | postoperative day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| maximal incision thickness | maximal incision thickness measured by anterior segment OCT at postoperative day 1, day 7, month 1, month 3 | postoperative day 1, day 7, month 1, month 3 |
| surgical induced-astigmatism |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yizhi Liu, PhD | Zhongshan Ophthalmic Center, Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Ophthalmic Center, Sun Yat-sen University | Guangzhou | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34647960 | Derived | Dai Y, Liu Z, Wang W, Han X, Jin L, Chen X, Jin G, Wang L, Zhang E, Qu B, Liu J, Congdon N, He M, Luo L, Liu Y. Incidence of Incision-Related Descemet Membrane Detachment Using Phacoemulsification With Trapezoid vs Conventional 2.2-mm Clear Corneal Incision: A Randomized Clinical Trial. JAMA Ophthalmol. 2021 Nov 1;139(11):1228-1234. doi: 10.1001/jamaophthalmol.2021.4148. |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D003226 | Congresses as Topic |
| ID | Term |
|---|---|
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
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| conventional 2.2mm microincision | Procedure | conventional 2.2mm coaxial microincision phacoemulsification |
|
surgical induced-astigmatism was calculated at each postoperative visit using the following equation: K2 = [K1 2 + K32 -2 K1 K3 cos (2θ3 -2θ1)]1/2
| postoperative day 1, day 7, month 1, month 3 |
| the length of DMD | the length of incision-site descemet membrane detachment measured by anterior segment OCT at postoperative day 1, day 7, month 1, month 3 | postoperative day 1, day 7, month 1, month 3 |
| Best corrected visual acuity (BCVA) | Best corrected visual acuity (BCVA) is evaluated with an ETDRS chart at each postoperative visit | postoperative day 1, day 7, month 1, month 3 |
| modulation transfer function (MTF)-cut off | modulation transfer function (MTF)-cut off measured by itrace at each postoperative visit | postoperative day 1, day 7, month 1, month 3 |
| central cornea endothelial cell loss | Central cornea endothelial cell loss was calculated on the basis of preoperative and postoperative endothelial cell density. | postoperative day 1, day 7, month 1, month 3 |